U.S. FDA UNIQUE DEVICE IDENTIFIER (UDI) AND GLOBAL UNIQUE DEVICE IDENTIFIER DATABASE (GUDID) REQUIREMENTS
The U.S. FDA requires medical device labelers to:
Include Unique Device Identifiers (UDI) on their device labels
Submit device information to the Global Unique Device Identification Database (GUDID)
Designate a Regulatory Contact for UDI purposes
ALN offers simple, low-cost solutions for FDA UDI and GUDID requirements.
For assistance with new FDA UDI and GUDID requirements, simply complete the form below.